Integrated locking device with passive sealing

ABSTRACT

Endoscope assemblies, biopsy caps, and methods for making and using the same. An example endoscope assembly may include an endoscope having a channel formed therein and a port that provides access to the channel. A cap may be coupled to the port. The cap may include a base having a securing member for securing the cap to the port, an outer shell, a locking member coupled to the outer shell, an inner seal member, and a central opening that extends to the channel. The inner seal member may include a plurality of flaps.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/054,407, filed May 19, 2008, the entire disclosure of which isincorporated herein by reference.

This application is related to U.S. patent application Ser. No.12/467,971, filed on even date herewith and entitled “Integrated LockingDevice with Active Sealing”, which claims the benefit of U.S.Provisional Application Ser. No. 61/054,393, filed May 19, 2008; U.S.patent application Ser. No. 12/467,968, entitled “Integrated LockingDevice with Fluid Control”, filed on even date herewith, which claimsthe benefit of U.S. Provisional Application No. 61/054,413, filed May19, 2008; and U.S. patent application Ser. No. 12/467,947, filed on evendate herewith and entitled “Biopsy Cap Attachment and Integrated LockingDevice”, which claims the benefit of U.S. Provisional Application Ser.No. 61/054,294, filed May 19, 2008, which disclosures are all herebyincorporated herein by reference. This application is also related toU.S. patent application Ser. No. 12/029,148, filed Feb. 11, 2008, thedisclosure of which is hereby incorporated herein by reference.

FIELD OF THE INVENTION

The present invention pertains to endoscopes, endoscope assemblies,guidetubes, introducers, and instrument caps for endoscopes, guidetubes,and introducers. More particularly, the present invention pertains tobiopsy caps for an access port of an endoscope.

BACKGROUND

A wide variety of endoscope assemblies and biopsy caps have beendeveloped. Of the known endoscope assemblies and biopsy caps, each hascertain advantages and disadvantages. There is an ongoing need toprovide alternative endoscope assemblies and biopsy caps as well asmethods for making and using the same.

BRIEF SUMMARY

The invention provides design, material, and manufacturing methodalternatives for endoscope assemblies and biopsy caps as well asprovides methods for making and using endoscope assemblies and biopsycaps.

An example endoscope assembly may include an endoscope having a channelformed therein and a port that provides access to the channel. A cap maybe coupled to the port. The cap may include a base having a securingmember for securing the cap to the port, an outer shell, a lockingmember coupled to the shell, an inner seal member disposed within theshell, and one or more openings extending through the cap and into thechannel. The inner seal member may include a plurality of flaps.

An example endoscope biopsy cap may include an outer shell having anopening formed therein and a base. A securing member may be disposed onthe base for securing the base to a port on an endoscope. A lockingmember may be coupled to the shell for securing the position of amedical device disposed in the opening. A multi-layer inner seal membermay be disposed within the shell.

Another example endoscope biopsy cap may include an outer shell havingan opening formed therein and a base. A securing member may be disposedon the base for securing the base to a port on an endoscope. A lockingmember may be coupled to the shell for securing the position of amedical device disposed in the opening. A plurality of sealing membersmay be disposed within the shell.

Another example endoscope biopsy cap may include an outer shell havingan opening formed therein and a base. A securing member may be disposedon the base for securing the base to a port on an endoscope. A lockingmember may be coupled to the shell for securing the position of amedical device disposed in the opening. A sealing member may be disposedwithin the shell. The sealing member may include a pair of openingsextending therethrough.

An example method for using an endoscope may include providing anendoscope having a channel formed therein and a port that providesaccess to the channel, disposing the endoscope within a body lumen of apatient, and disposing a cap on the port. The cap may include an outershell having an opening formed therein and a base. A securing member maybe disposed on the base for securing the base to the port. A lockingmember may be coupled to the shell for securing the position of amedical device disposed in the opening. An inner seal member may bedisposed within the shell. The inner seal member may include a pluralityof flaps.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present invention.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a perspective view of an example endoscope assembly;

FIG. 2 is an exploded view of a portion of the example endoscopeassembly shown in FIG. 1 illustrating a biopsy cap;

FIG. 3 is a cross-sectional view of another example biopsy cap;

FIG. 4 is a cross-sectional view of another example biopsy cap;

FIG. 5 is a partial cross-sectional side view of another example biopsycap;

FIG. 6 is a partial cross-sectional side view of another example biopsycap;

FIG. 7 is a partial cross-sectional side view of another example biopsycap;

FIG. 8 is a partial cross-sectional side view of another example biopsycap;

FIG. 9 is a perspective view of an example securing member;

FIG. 10 is a perspective view of another example securing member;

FIG. 11 is a perspective view of another example securing member;

FIG. 12A is a perspective view of another example securing member in afirst configuration;

FIG. 12B is a perspective view of the example securing memberillustrated in FIG. 12A in a second configuration;

FIG. 13 is a perspective view of another example securing member;

FIG. 14 is a perspective view of another example securing member;

FIG. 15A is a perspective view of an example locking member in a firstconfiguration;

FIG. 15B is a perspective view of the example locking member illustratedin FIG. 15A in a second configuration;

FIG. 16 is a perspective view of another example locking member;

FIG. 17A is a perspective view of another example locking member;

FIG. 17B is a perspective view of an alternative locking member to thatdepicted in FIG. 17A;

FIG. 17C is a perspective view of the alternative locking member of FIG.17B showing further details;

FIG. 18 is a perspective view of another example locking member;

FIG. 19 is a perspective view of another example locking member;

FIG. 20 is a perspective view of another example locking member;

FIG. 21A is a perspective view of another example locking member in afirst configuration;

FIG. 21B is a perspective view of the example locking member illustratedin FIG. 21A in a second configuration;

FIG. 22A is a perspective view of another example locking member in afirst configuration;

FIG. 22B is a perspective view of the example locking member illustratedin FIG. 22A in a second configuration;

FIG. 23A is a perspective view of another example locking member in afirst configuration;

FIG. 23B is a perspective view of the example locking member illustratedin FIG. 23A in a second configuration; and

FIG. 24 is a perspective view of another example locking member.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be appliedunless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

An example endoscope and/or endoscope assembly 10 is illustrated inFIG. 1. Endoscope 10 may be any of a number of types of endoscopes orrelated medical devices usually identified by the particular anatomydesired to be reached. For example, endoscope 10 may be a bronchoscope,colonoscope, duodenoscope, esophagoscope, guidetubes, introducers(without or without vision or visualization capabilities), or any othertype of endoscope or related medical device. Endoscope 10 may include ahandpiece 12 and an elongate shaft 14 extending distally from handpiece12 to a distal tip 18. Shaft 14 may include a lumen defining a workingchannel 16 extending through shaft 14 from a distal end 19 near distaltip 18 of shaft 14 to an access port 20 that may be positioned inhandpiece 12 or another portion of endoscope 10. Although endoscope 10is depicted with a single working channel in FIG. 1, it can beappreciated that in other embodiments, endoscope 10 may include multipleworking channels, as desired.

Handpiece 12 may include one or a plurality of controls 22, such asrotating knobs, which may be used to control movement of distal tip 18of shaft 14 during operation. For example, a first rotating knob 22 amay control up and down movement or deflection of distal tip 18 of shaft14, while a second rotating knob 22 b may control side-to-side movementor deflection of distal tip 18 of shaft 14. Handpiece 12 may alsoinclude one or a plurality of buttons 24, which may be used to activatesuction or deliver fluid such as air, saline and/or water, etc. througha lumen of the endoscope 10 or perform other functions as desired.Additionally, handpiece 12 may include an optical cable 26 connected toan external light source (not shown).

Turning now to FIG. 2, here access port 20 of handpiece 12, whichprovides access to working channel 16 of endoscope 10, is illustrated.Access port 20, which may extend from the side of endoscope 10 or atanother location, may include a coupling portion 28 for coupling a cap30 to access port 20. Cap 30, which may be removably attached orpermanently attached to access port 20, may provide access for insertingand/or advancing an endoscopic device through working channel 16 ofendoscope 10.

Caps like cap 30, which may be termed “biopsy caps”, are often designedwith several functions in mind. For example, cap 30 may form a fluid/airbarrier to working channel 16 that may help control insufflation andbile fluid egress therefrom that later have the potential to spill ontothe clinician's hands and/or the floor thereby interfering with theintervention and/or become a biohazard. In addition, cap 30 may have anopening 32 extending therethrough. Opening 32 may be in fluidcommunication with working channel 16 and it may reduce the size of theopening 34 of working channel 16, for example, to accommodate anendoscopic device or instrument. Thus, caps like cap 30 may be much likean adapter in that it forms a physical transition at opening 34 ofworking channel 16 (or other instrument channels or access points) sothat it transitions to a size more closely to that of the device to beinserted into working channel 16. Some additional discussion regardingbiopsy caps can be found in U.S. Patent Application Pub. Nos.US20070293719A1, US20070244356A1, and US20070238928A1, the entiredisclosures of which are herein incorporated by reference.

A number of additional biopsy caps are contemplated that incorporate atleast some of the desirable features of biopsy caps as well as haveother desirable characteristics. The forgoing discussion discloses someof the embodiments of caps that are contemplated. These caps may includea passive seal. For the purposes of this disclosure, a passive seal is aseal that seals endoscope 10 at port 20 so as to prevent the leakage ofbodily fluids and/or air. In addition, by virtue of being “passive”, thecaps disclosed herein are configured to seal off endoscope 10 at port 20without the need of any so-called “active” processes or steps by theclinician.

Turning now to the remaining figures, FIG. 3 is a partialcross-sectional side view of biopsy cap 130, which may be similar inform and function to other caps disclosed herein. Here it can be seenthat cap 130 may include an outer shell 136, a securing member 140 thatmay help to secure cap 130 to port 20, one or more locking members 142coupled to shell 136, and an inner seal member 144 disposed within outershell 136. Outer shell 136 may take a number of different shapes andforms. In general, however, outer shell 136 may be made from arelatively rigid or hard polymer/plastic, a metal or metal alloy, aceramic, and the like, or combinations thereof and may take a formresembling an exoskeleton or protective covering over the more delicateinterior (e.g., seal member 144). In addition, by virtue of formingouter shell 136 from a relatively rigid material, a number ofaccessories to and/or structural components of cap 130 may be secured toor integrally formed with shell 136. For example, securing member 140and/or locking members 142 may be secured to or integrally formed withouter shell 136.

Outer shell 136 may have one or more apertures 146 formed therein.Apertures 146, for example, may be disposed on a top surface or surfacethat is opposite securing member 140, although any other suitableportion of outer shell 136 may include apertures 146 including the sidesor side surfaces. Apertures 146 may be the entrance point or otherwisedefine one or more openings that extend through cap 130 into channel 16when cap 130 is seated on port 20. For example, apertures 146 may extendthrough outer shell 136 and provide access to slits 148, which may beformed in seal member 144. Thus, apertures 146 may form the exterioropening in cap 130 where other medical devices (e.g., guidewires,catheters, etc.) can be passed through so as to gain access to workingchannel 16 via slits 148.

To ease the ability of a user to pass a medical device through apertures146, apertures 146 may have a chamfered or beveled edge, which mayfunction like a funnel to guide the medical device into aperture. Inaddition to the funneling function that may be realized by the inclusionof beveled apertures 146, apertures 146 may also provide cap 130 with anumber of additional desired characteristics. For example, becauseapertures 146 are formed in the relatively rigid outer shell 136 andbecause they are generally positioned a distance away from port 20,apertures 146 and/or outer shell 136 may also function as a strainrelief that may relieve strain that might otherwise be applied toendoscope 10 (e.g., at port 20), for example, during device exchanges ortransfers. Thus, the shear stress that may be generated during deviceexchanges can be shifted away from endoscope 10, which may improve theability of cap 130 to maintain a good seal at port 20.

Securing member 140 may be disposed on a bottom surface of cap 130. Insome embodiments, a sealing disk or sleeve 138 may be disposed adjacentsecuring member 140. Disk 138 may desirably impact the seal formedbetween cap 130 and port 20. Securing member 140 may take any number ofa wide array of forms including those disclosed herein. For example,securing member 140 may include a pair of tabs 150 a/150 b, which maysnap onto or otherwise secure to port 20. Securing tabs 150 a/150 b ontoport 20 may include, for example, snapping tabs 150 a/150 b onto anarrowed ring or portion of port 20. This may include snapping tabs 150a/150 b onto port from a peripheral or side region of port 20. Inaddition, a portion of shell 136 may include a cutout or notch (notshown) that may provide some structural relief for securing member 140and that may allow tabs 150 a/150 b to have greater flexibility whensecuring cap 130 to port 20. The precise form of securing member 140and/or tabs 150 a/150 b may vary. For example, a different number oftabs may be utilized, differently shaped tabs may be utilized or adifferent securing system altogether may be utilized for securing cap130 to port 20. Furthermore, various adaptors may be provided to createa suitable connection between cap 130 and port 20 if such a connectioncannot be easily made with tabs 150 a/150 b or another suitable securingmember 140. Examples of some of the various alternative securing members140 contemplated can be found below.

Locking members 142 may be generally disposed adjacent the top surfaceof cap 130 and they may be used to secure and/or hold the position of adevice (e.g., a guidewire, catheter, etc.) extending through cap 130into channel 16. However, locking members 142 may be disposed on anysuitable surface of cap 130 and/or shell 136. Locking members 142 mayalso be integrally formed with shell 136. In addition to holding theposition of a device, locking members 142 may also tend to guide thesedevices away from the center of cap 130 so that other device may gainaccess to channel 16 via cap 130. In at least some embodiments, lockingmembers 142 may include one or more bends or “hooks” formed therein thata medical device may be wrapped around or pressed against to hold itsposition. The number of locking members 142 may vary. In someembodiments, one locking member 142 is utilized. In other embodiments,two, three, four, five, six, or more locking members 142 are utilized.In addition, the precise form of locking members 142 may also vary. Forexample, locking member 142 may or may not include a wing or flap thatmay tend to direct a device toward locking member 142. Examples of someof the various alternative locking members 142 contemplated can be foundbelow.

Seal member 144 may comprise a soft material such as a plastic or foamthat may be suitable for sealing about a medical device extendingtherethrough. The precise form and materials for seal member 144 mayvary. For example, seal member 144 may include a pliable or formablematerial that may or may not be absorbent. In some embodiments, sealmember 144 may include those materials used for similar structuresdisclosed in U.S. Pat. No. 6,663,598, the entire disclosure of which isherein incorporated by reference. In at least some embodiments, sealmember 144 may substantially fill the interior of shell 136.Alternatively, a portion of the interior of shell 136 may lack sealmember 144 and may be used, for example, to hold bodily fluids that mayescape from port 20. In still further embodiments, a portion of sealmember 144 may extend out from shell 136 and it may define or otherwisefunction as a strain relief.

As indicated above, seal member 144 may have one or more slits 148extending therethrough. Accordingly, medical device(s) may be advancedthrough apertures 146, through slits 148, and into working channel 16for use as part of a medical intervention. The precise number of slits148 may vary. For example, seal member 144 may include one, two, three,four, five, six, or more slits 148. In embodiments where multiple slits148 are utilized, seal member 144 may be configured so that each medicaldevice (which may generally have a round cross-sectional shape) can bedisposed in its own slit 148. This arrangement may be desirable becauseit may allow seal member 144 to seal more effectively around eachmedical device as opposed to the sealing of multiple medical devicesthrough a single slit, which may create gaps adjacent the edges of thedevices where bodily fluids may have a chance to escape or otherwiseleak from the biopsy cap.

In some embodiments, a portion of seal member 144 (e.g., a portionadjacent apertures 146) may be chamfered so that it may help guide orfunnel devices through slits 148. Seal member 144 may extend laterallyto the edges (and/or the top) of shell 136. This may help to prevent orreduce the amount of fluids that may migrate into and out from cap 130.Alternatively, a gap may be formed between the top of seal member 144and the top of the interior of shell 136. The gap may provide an areafor fluids to collect that may escape seal member 144 and that mayotherwise “splash” during, for example, device removal or exchange.

Another example cap 230 is illustrated in FIG. 4. Cap 230 may includeshell 236, securing member 240, locking member 242, and seal member 244.Cap 230 may be similar in form and function to other caps disclosedherein. For example, shell 236 may be similar to shell 136. Securingmember 240 may be similar to securing member 140 and it may include apair of locking tabs 250 a/250 b that each have a lip or ridge 251 thatmay improve the ability of securing member 240 to attach to port 20.Locking member 242 may include a body that splits into two arms 252a/252 b. Each arm 252 a/252 b may include a wire lock 254, which maytake the form of a notch that a medical device (e.g., a guidewire,catheter, etc.) may be wedged into so that its position relative to thecap can be secured. In at least some embodiments, locks 254 may bepositioned adjacent a bend or curve defined in arms 252 a/252 b so thatthe shape and/or configuration of arms 252 a/252 b may funnel or directthe medical device toward locks 254. This may simplify the process ofdisposing the medical device within locks 254.

Seal member 244 may include a plurality of flaps or membranes 256. Flaps256 may take the form of flexible membranes of material that may pressand seal against a device extending therethrough. Flaps 256 may bearranged, for example, in a series of horizontal layers that are stackedvertically. Each layer may include one or more flaps 256 that may or maynot overlap with one another. Numerous other arrangements are alsocontemplated. By arranging flaps 256 in the manner illustrated in FIG.4, each layer or set of flaps 256 may form a “seal” such that flaps 256may define a plurality of seals. If one of these seals (e.g., the layerof flaps 256 closest to securing member 240) should be compromised, anadjacent seal would maintain the integrity of seal member 244, and soon. Thus, the multi-layer design of seal member 244 may enhance theability of cap 230 to prevent the leakage of bodily fluids during amedical intervention.

The number of flaps 256 utilized in seal member 244 as well as thenumber of layers may vary. For example, each layer may include one, two,three, four, five, six, seven, eight, or more flaps 256. Likewise, sealmember 244 may include one, two, three, four, five, six, seven, eight,or more layers of flaps 256. In some embodiments, each layer may includethe same number of flaps 256. In other embodiments, differing numbers offlaps 256 may be used in different layers.

FIGS. 5-8 illustrate other example caps, which may be similar in formand function to other caps disclosed herein that utilize different sealmembers. Some of the example securing members and locking members thatmay be utilized for these caps are omitted from the drawings forsimplicity purposes. It can be appreciated that these caps may utilizeany suitable securing member, locking member, or other structure(s), asappropriate, without departing from the spirit of the invention.

Turning now to FIG. 5, here cap 330 can be seen. Cap 330 may includeseal member 344, which may include a plurality of fingers 356 that eachmay have a pad 358 attached thereto. Pads 358 may include any suitablematerial including a sealing foam, a sealing polymer/plastic, any othersuitable material for sealing, and the like. In some embodiments, pads358 may structurally extend into two planes so that they have a shapethat helps to “funnel” or guide a device through fingers 356. Fingers356 may extend radially inward from shell 336. In at least someembodiments, fingers 356 may be made from a relatively elastic orresilient material that may be biased to extend inward from shell 336.Alternatively, a spring or other biasing structure (including, forexample, a living spring or hinge, a spring with a varying pitch, aballoon or inflatable member, and the like) may be used to hold fingers356 in the desired position. The spring may be designed to hold arelatively constant amount of pressure on fingers 356 so thatsubstantially constant sealing pressure can be transferred onto a deviceextending therethrough.

When a device 360 (e.g., a guidewire, catheter, etc.) is advancedthrough cap 330, fingers 356 may seat against and seal around device360. Because of the configuration of fingers 356, fingers 356 can shiftslightly in position to accommodate device 360 (i.e., thereby overcominga portion of the bias) and then return to their original position.Accordingly, when device 360 is removed, fingers 356 may return to amore radially inward position so as to close off and seal the opening(s)extending through cap 330.

The configuration and arrangement of seal member 344 may vary. Forexample, in some embodiments, two fingers 356 may be utilized.Alternatively, three, four, five, six, or more fingers 356 may beincluded. In addition, multiple pads 358 may be included on one or moreof fingers 356. In these and other embodiments, fingers 356 may bearranged in essentially any suitable pattern within cap 330 including,for example, a generally circular pattern that forms a point for device360 to pass through cap 330 and into channel 16. Other arrangements arecontemplated including non-circular patterns, patterns with multiplepoints for device 360 to pass through, etc.

FIG. 6 illustrates another cap 430 that may be similar to cap 330 (andother caps disclosed herein). Cap 430 may include fingers 456 having asealing material or pads 458 attached thereto. Just like fingers 356,fingers 456 may be biased to extend radially inward to seat againstdevice 460. However, fingers 456 may each include a tether 462 that may,for example, relieve some of the bias and make it easier for device 460to extend therethrough. In addition, cap 430 may include a top seal 464.Top seal 464 may include any suitable sealing material and may have oneor more openings formed therein for device 460 to extend therethrough.

FIG. 7 illustrates another cap 530 that may be similar to other capsdisclosed herein. Cap 530 may include fingers 556 having pads 558attached thereto. Just like fingers 356/456, fingers 556 may be biasedto extend radially inward to seat against device 560. Cap 530 may alsoinclude a sealing substance, fluid, and/or gel 566 disposed adjacentfingers 556. Gel 556 may help to further prevent unwanted fluid and/orair leakage from cap 530. In some embodiments, gel 566 may include apetroleum jelly or similar substance such as VASELINE® petroleum jellyand/or KY® jelly. Alternatively, gel 566 may include a hygroscopicmaterial that may expand upon absorption of fluids and may placeadditional sealing force on device 560. In addition, cap 530 may includea top seal 564, which may be similar to seal 464. Furthermore, caps likecap 530 or any other cap disclosed herein may include another sealingfeature such as an inflated structure (e.g., an inflatable member orballoon including a hollow cylinder balloon, etc.), a filled structure(e.g., a sealing foam, a sealing coating, etc.), and the like,combinations thereof, or any other suitable feature.

FIG. 8 illustrates another cap 630 that may be similar to other capsdisclosed herein. Cap 630 may include fingers 656 having wheels orrollers 668 attached thereto. Besides having wheels 668 attachedthereto, fingers 656 may be otherwise similar to fingers 356/456/556.For example, fingers 656 may be biased to extend radially inward andseat against device 660. Wheels 668 may configured to seat against andseal device 660. Because wheels 668 may be able to rotate within cap630, wheels 668 may improve the ability of device 660 to pass throughcap 630 during an intervention and may reduce the friction betweenwheels 668 and device 660.

FIGS. 9-15 illustrate some examples of securing members that may beutilized in any of the biopsy caps disclosed herein. For example, FIG. 9illustrates securing member 740, which may be similar to securingmembers 140/240 and/or other securing members disclosed herein. Securingmember 740 may include a pair of locking tabs 750 a/750 b that may befitted onto and secured to port 20. Tabs 750 a/750 b, which may besimilar to tabs 150 a/150 b and/or 250 a/250 b, may be configured tosnap onto port 20. In some embodiments, tabs 750 a/750 b may include aridge 751. Ridge 751 may help to hold securing member 740 onto port 20and/or mate with another ridge 751 or groove that may be formed on port20.

FIG. 10 illustrates another example securing member 840, which may beutilized in conjunction with any of the caps disclosed herein. Securingmember 840 may include a plug or stopper 870 that may be configured tofit within port 820 in a manner similar to a cork or elastomericstopper. Indeed, plug 870 may be made from similar materials including,for example, silicone, cork, an elastomer, rubber, and the like or othersuitable sealing materials. In addition, securing member 840 may alsoinclude a ridge 872 that helps to hold securing member 840 in place, forexample, adjacent a ridge 874 formed on the end of port 820.Alternatively, port 820 may include a groove (not shown) that isconfigured to mate with ridge 872.

FIG. 11 illustrates another example securing member 940. Securing member940 may include a plurality of leaf-like fingers 976. Fingers 976 may beconfigured to shift between a first or “open” position (depicted inphantom) and a second or “closed” position, the later being used to holdsecuring member 940 onto an access port. In some embodiments, fingers976 may grasp onto or hold onto a side portion of the access port and/orthe endoscope. Alternatively, fingers 976 may wrap around (e.g., theback side of) the access port and/or endoscope.

In at least some embodiments, fingers 976 are made from a deformablematerial that allows them to shift between the first and secondpositions and hold the desired shape/position. Leaf-like fingers 976 maybe utilized alone as a securing member 940, as shown, or as a secondaryattachment means by combining them with other securing members 940.

FIGS. 12A and 12B illustrate another example securing member 1040.Securing member 1040 may include an end with a deformable or flexibleopening 1078 that is configured to shift between a narrowedconfiguration (illustrated in FIG. 12A) and an expanded configuration(illustrated in FIG. 12B). When in the expanded configuration, opening1078 may be fitted over a portion of port 1020, for example, such as aflange or ridge 1080 on port 1020. Shifting may be accomplished by thenature of the material in which opening 1078 is formed. For example, theend of securing member 1040 may include a flexible polymer, anelastomer, silicone, rubber, and the like, or any other suitablematerial that may be resilient enough to undergo the necessary shifts insize. Once seated, opening 1078 may shift or partially shift back to thenarrowed configuration and seal about port 1020.

FIG. 13 illustrates another example securing member 1140 that may besimilar in form and function to other securing members disclosed herein.Securing member 1140 may include a plurality of tabs 1150 a/1150 bhaving threads 1182 formed thereon. Other than having threads 1182formed thereon, tabs 1150 a/1150 b may be similar to tabs 150 a/150 b,tabs 250 a/250 b, and/or tabs 750 a/750 b. Securing member 1140 may beconfigured to attach to an access port by threading onto the port (e.g.,port 20 or a version of port 20 with corresponding threads).

FIG. 14 illustrates another example securing member 1240 that may besimilar in form and function to other securing members disclosed herein.Securing member 1240 may include a “quick release” pull tab 1284. Tab1284 may be disposed on the end of port 1220. In some embodiments, tab1284 may include an adhesive that is configured to form a seal at port1220 and thus hold the biopsy cap onto port 1220. In addition, theadhesive in tab 1284 may be disrupted or pulled thereon, for example ata pull point 1285, so that the cap can be quickly and easily removedfrom port 1220, as desired.

In addition to those securing members disclosed herein, any of the capsdisclosed herein may alternatively include other suitable securingmembers without departing from the spirit of the invention. For example,other securing members may include, but are not intended to be limitedto, lock and key designs, slidable or depressible button locks that maycatch or otherwise secure onto the port, long sleeves that are disposedover the port, fasteners that includes adhesives includingpressure-sensitive adhesives (e.g., that may be analogous to those usedon canning lids), and the like. The same may also be true of the variouslocking members disclosed below.

FIGS. 15A-20 illustrate example locking members that may be utilizedwith any of the biopsy caps disclosed herein. These locking members maybe attached to a biopsy cap at any suitable position thereon and theymay be used to secure the position of a medical device (e.g., aguidewire, catheter, etc.) relative to the cap (and/or endoscope 10).Just like was the case for the securing members disclosed above, some ofthe additional cap structure is omitted from FIGS. 15A-20 for simplicitypurposes. However, it can be appreciated that any of the locking membersshown and contemplated may be attached to a biopsy cap usingconventional methods to achieve the desired result.

FIGS. 15A and 15B illustrate locking member 1342, which may beconfigured to shift between a first configuration (as illustrated inFIG. 15A) and a second configuration (as illustrated in FIG. 15B).Locking member 1342 may include a pair of actuating arms 1386 that, whenactuated, shift a locking ring 1388 from the first or smallerconfiguration that defines a smaller diameter D1 to the second or largerconfiguration that defines a larger diameter D2. Locking member 1342 maybe described as being a spring clip or spring wing as locking ring 1388may include a plurality of loops of material with a spring-likeconfiguration. The extra portion or loops of the “spring” may beutilized to accommodate the expansion in size of ring 1388. In at leastsome embodiments, locking member 1342 may have a form similar to a clipthat may be used to secure weights onto a barbell.

Although not shown, locking member 1342 may be attached to a biopsy capat any suitable location using any suitable means. For example, aportion of arms 1386 and/or ring 1388 may be directly attached to a cap.Alternatively, an arm or member may extend from the cap that attaches tolocking member 1342. In still other embodiments, locking member 1342 mayinclude an additional structure such as a clip to removably securelocking member 1342 to a cap. These later embodiments of locking member1342 and other locking members may be desirable because they may allowdifferent types of locking members to be “mixed and matched” based ontheir particular applicability to a given intervention. It can beappreciated that a number of securing members are also contemplated thattake a form similar to locking member 1342 and that are used to secure acap to a port.

FIG. 16 illustrates another example locking member 1442, which may beused with any of the biopsy caps disclosed herein. Locking member 1442may have a wedge-like shape and may have a channel or groove 1490 formedtherein where device 1460 (e.g., a guidewire, catheter, etc.) can bedisposed therein and held by friction. Just like the other lockingmembers disclosed herein, locking member 1442 may be attached to abiopsy cap at any suitable location using any suitable means.

FIG. 17A illustrates another example locking member or locking assembly1542, which may be used with any of the biopsy caps disclosed herein.Locking member 1542 may include a plurality of locking featuresincluding, for example, a pair of arms 1552 a/1552 b that are coupled toor integrally formed on shell 1536. Arms 1552 a/1552 b may be shaped ina manner that may allow them to secure the position of a device (e.g., aguidewire, catheter, etc.). For example, arms 1552 a/1552 b may includeone or more bends, hooks, grooves, and/or the like. Locking member 1542may also include another locking structure or arm 1552 c that may bedisposed below arms 1552 a/1552 b. By virtue of having this position,arm 1552 c may be used in conjunction with one or more of arms 1552a/1552 b to allow the device to be wrapped around the desiredcombination of structures 1552 a/1552 b/1552 c.

As illustrated in FIG. 17B, which is a rotated view of the lockingmember 1542 of FIG. 17A, the arm 1552 c is shaped to create slottedopenings 1555 a/1555 b in cooperation with the opening 1556 in the upperend of the shell. In some embodiments, the slotted opening is shapedwith a narrowed opening which expands into a larger instrument holdingarea that has contoured surfaces for easy placement and removal of aninstrument.

FIG. 17C provides further detail of an exemplary design of arm 1552 c.As indicated, the surface of arm 1552 c is contoured to provide easymovement of a guidewire or instrument around its surface. Further, theedge 1557 includes an open shoulder 1558 along the lower portion of thelateral surface of arm 1552 c. This surface helps prevent instrumentsfrom catching on arm 1552 c.

FIG. 18 illustrates another example locking member 1642, which may beused with any of the biopsy caps disclosed herein. Locking member 1642may include a base 1692 having an opening 1614 formed therein. Device1660 may extend through opening 1614. A spring button 1696 may beattached to base 1692. Spring button 1696 may be coupled to a spring(not shown) that biases a portion of button 1696 (e.g., a rear portionof button 1696 that may be disposed within base 1692 on the oppositeside of opening 1614) into opening 1614, thereby “closing” or “locking”opening 1614. Depressing button 1696 may overcome the bias and openopening 1614 so that device 1660 can be extended therethrough. Releasingbutton 1696 allows the spring to press button 1696 back into the biasedposition and lock the position of device 1660.

A number of different configurations are contemplated for locking member1642. For example, locking member 1642 may have a barrel-like orcylindrical shape rather than the more squared or rectangular shape asshown. In addition, locking member 1642 may include a lock that canreversibly hold button 1696 in the desired position such as, forexample, the locked position.

FIG. 19 illustrates another example locking member 1742, which may beused with any of the biopsy caps disclosed herein. Locking member 1742may include a pair of arms 1786 that can be actuated to open/closeopening 1794 to secure device 1760. Locking member 1742 may function ina manner similar to a clothespin. As such, locking member 1742 mayinclude a spring or other biasing member (not shown) that holds it ineither the open (e.g., “unlocked”) or closed (e.g., “locked”) positions.

FIG. 20 illustrates another example locking member 1842, which may beused with any of the biopsy caps disclosed herein. Locking member 1842may include a base 1892 having opening 1894 formed therein. Device 1860may extend therethrough. A pair of buttons 1896 a/1896 b may be attachedto base 1892 for opening/closing opening 1894. For example, one of thebuttons (e.g., button 1896 b) may be depressed to “lock” device 1860while the other button (e.g., button 1896 a) may be depressed to open or“unlock” device 1860.

FIGS. 21A and 21B illustrate locking member 1942, which may beconfigured to shift between a first or open configuration (asillustrated in FIG. 21A) and a second or closed configuration (asillustrated in FIG. 21B). Locking member 1942 may include a pair ofopposing sets of fingers 1998 a/1998 b coupled to a base 1999 that areconfigured to shift from the upright or open first position to thehorizontal or flat second configuration, the later being configured tosecure the position of device 1960. FIGS. 22A and 22B illustrate lockingmember 2042, which may be similar in form and function to locking member1942. Locking member 2042 may include a pair of opposing sets of fingers2098 a/2098 b coupled to a base 2099. Device 2060 may extend throughfingers 2098 a/2098 b as shown in FIG. 22A, which may hold device 2060in place, for example, by friction. Alternatively, device 2060 may bewrapped around fingers 2098 a/2098 b, as shown in FIG. 22B.

In some embodiments, bases 1999 and/or 2099 may be generally planar. Inother embodiments, bases 1999 and/or 2099 may be curved so as to beconvex, concave, or have another shape. Moreover, bases 1999 and/or 2099may change from one shape to another upon actuation of fingers 1998a/1999 b and/or 2098 a/2098 b. For example, bases 1999 and/or 2099 maybe generally planar when fingers 1998 a/1999 b and/or 2098 a/2098 b arein the open position and bases 1999 and/or 2099 may shift to a concaveshape when fingers 1998 a/1999 b and/or 2098 a/2098 b shift to the flatconfiguration. Alternatively, bases 1999 and/or 2099 may shift fromconcave to planar, convex to planar, planar to convex, etc.

A number of alternatives are also contemplated for fingers 1998 a/1999 band/or 2098 a/2098 b. For example, fingers 1998 a/1999 b and/or 2098a/2098 b may be interconnected so that the shifting of one fingerresults in the shifting of all the fingers. Alternatively, flaps may beused instead of or in addition to fingers 1998 a/1999 b and/or 2098a/2098 b that extend down at least a portion of the length of bases 1999and/or 2099 and that are configured to shift between an open and aclosed configuration.

Base 1999/2099 of locking members 1942/2042 may desirably add a surfacesubstrate that may allow these devices to be attached to a biopsy cap.In some embodiments, base 1999/2099 may include a strip of polymer orplastic that can be bonded to a biopsy cap with a permanent adhesive. Inother embodiments, base 1999/2099 may be configured to be removablyattached to the biopsy cap. For example, a removable or temporaryadhesive may be used, base 1999/2099 may be “velcroed” onto the cap,etc.

FIGS. 23A and 23B illustrate locking member 2142, which may beconfigured to shift between a first configuration (as illustrated inFIG. 23A) and a second configuration (as illustrated in FIG. 23B).Locking member 2142 may include a base 2199 a including a platformregion 2199 b. Region 2199 b may include a hook-like extension 2198 thatextends through an opening 2194 in base 2199 a and that can grasp device2160 when actuated (as illustrated in FIG. 23A). Region 2199 b may behingedly connected to base 2199 a so that region 2199 b can be moved upor down, as desired, to engage device 2160. In alternative embodiments,multiple hook-like extensions 2198 may be utilized. Furthermore,hook-like extensions 2198 having different shapes may also be utilizedsuch as longer hooks, wider hooks, two or more opposing hooks, eyelets,etc.

FIG. 24 illustrates another example locking device 2260, which may beused with any of the biopsy caps disclosed herein. Device 2260 mayinclude a pair of arm segments 2286 a/2286 b coupled together by alinkage 2286 c. Linkage 2286 c may be slidable within one of the armsegments 2286 a/2286 b so that arms 2286 a/2286 b can be brought intocloser contact with one another by pinching together arms 2286 a/2286 band locking the position of device 2260. Manually moving arms 2286a/2286 b further apart may release device 2260.

In some embodiments, one or more additional locking members may be addedto a cap. The additional locking member may take any suitable formincluding any of those disclosed herein. Adding the locking members mayinclude fastening, snapping on, or hingedly connecting an externallocking member assembly onto the cap. Some additional discussion of wireor other locking devices which may be suitable for use with a biopsy capmay include U.S. Patent Application Pub Nos. US20060229496A1,US20050148820A1, and US20040106852A1 as well as U.S. Pat. Nos.7,060,052, 7,037,293, 6,893,393, 6,663,597, and 6,096,009, the entiredisclosures of which are herein incorporated by reference.

The various caps as well as the various components thereof may bemanufactured according to essentially any suitable manufacturingtechnique including molding, casting, mechanical working, and the like,or any other suitable technique. Furthermore, the various structures mayinclude materials commonly associated with medical devices such asmetals, metal alloys, polymers, metal-polymer composites, ceramics,combinations thereof, and the like, or any other suitable material.These materials may include transparent or translucent materials to aidin visualization during the procedure. Some examples of suitable metalsand metal alloys include stainless steel, such as 304V, 304L, and 316LVstainless steel; mild steel; nickel-titanium alloy such aslinear-elastic and/or super-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; combinationsthereof; and the like; or any other suitable material.

Some examples of suitable polymers may include polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example, DELRIN® availablefrom DuPont), polyether block ester, polyurethane, polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like.

In at least some embodiments, portions or all of the structuresdisclosed herein may also be doped with, made of, or otherwise include aradiopaque material. Radiopaque materials are understood to be materialscapable of producing a relatively bright image on a fluoroscopy screenor another imaging technique during a medical procedure. This relativelybright image aids the user of endoscope 10 in determining its location.Some examples of radiopaque materials can include, but are not limitedto, gold, platinum, palladium, tantalum, tungsten alloy, polymermaterial loaded with a radiopaque filler, and the like. Additionally,radiopaque marker bands and/or coils may be incorporated into the designof endoscope 10 or the various components thereof to achieve the sameresult.

In some embodiments, a degree of MRI compatibility may be imparted intothe structures disclosed herein. For example, to enhance compatibilitywith Magnetic Resonance Imaging (MRI) machines, it may be desirable tomake a portion of endoscope 10 in a manner that would impart a degree ofMRI compatibility. For example, a portion of endoscope 10 may be made ofa material that does not substantially distort the image and createsubstantial artifacts (artifacts are gaps in the image). Certainferromagnetic materials, for example, may not be suitable because theymay create artifacts in an MRI image. A portion of endoscope 10 may alsobe made from a material that the MRI machine can image. Some materialsthat exhibit these characteristics include, for to example, tungsten,cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g.,UNS: R30035 such as MP35-N® and the like), nitinol, and the like, andothers.

In addition, portions or components of the structures (including thevarious securing members, locking members, etc.) disclosed herein may becoated with a relatively soft material that may improve grip such as athermoplastic elastomer. The coating may or may not include additionalfeatures that may improve grip such as ridges, surface textures, bumps,grooves, projections, etc.

Furthermore, the various structures disclosed herein may be designed forsingle use or may be designed for repeated uses. Thus, the structuresdisclosed herein may be manufactured from materials that can withstandmultiple sterilizations and/or cleanings. This may be true of entirecaps, as disclosed herein, or any of the various features of any of thecaps.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

1. A medical instrument assembly, comprising: an endoscope having achannel formed therein and a port that provides access to the channel;and a cap coupled to the port, the cap including a base having asecuring member for securing the cap to the port, an outer shell, alocking member coupled to the outer shell, an inner seal member disposedwithin the outer shell, and one or more openings extending through thecap and into the channel, wherein the inner seal member includes aplurality of layers of flaps that are vertically separated from oneanother.
 2. The assembly of claim 1, wherein at least some of the flapsare horizontally oriented within the outer shell.
 3. The assembly ofclaim 1, wherein each of the layers of flaps includes two flaps.
 4. Theassembly of claim 1, wherein each of the layers of flaps includes threeor more flaps.
 5. A medical instrument assembly, comprising: anendoscope having a channel formed therein and a port that providesaccess to the channel: a cap coupled to the port, the cap including abase having a securing member for securing the cap to the port, an outershell, a locking member coupled to the outer shell, an inner seal memberdisposed within the outer shell, and one or more openings extendingthrough the cap and into the channel; wherein the inner seal memberincludes a plurality of flaps; wherein the plurality of flaps includes aplurality of fingers disposed within the outer shell; and wherein atleast some of the plurality of fingers include a sealing materialdisposed on an end surface of the fingers.
 6. A medical instrumentassembly, comprising: an endoscope having a channel formed therein and aport that provides access to the channel; a cap coupled to the port, thecap including a base having a securing member for securing the cap tothe port, an outer shell, a locking member coupled to the outer shell,an inner seal member disposed within the outer shell, and one or moreopenings extending through the cap and into the channel; wherein theinner seal member includes a plurality of flaps; wherein the pluralityof flaps includes a plurality of fingers disposed within the outershell; and wherein at least some of the plurality of fingers include atether attached to an end surface of the fingers.
 7. An endoscope biopsycap, comprising: an outer shell having an opening formed therein and abase; a securing member disposed on the base for securing the base to aport on an endoscope; a locking member coupled to the outer shell forsecuring the position of a medical device disposed in the opening; and amulti-layer inner seal member disposed within the outer shell, whereinthe multi-layer inner seal includes a plurality of horizontally-orientedgroups of flaps that are stacked vertically.
 8. The cap of claim 7,wherein each of the horizontally-oriented groups of flaps themulti-layer inner seal includes two flaps.
 9. The cap of claim 7,wherein each of the horizontally-oriented groups of flaps themulti-layer inner seal includes three or more flaps.
 10. An endoscopebiopsy cap, comprising: an outer shell having an opening formed thereinand a base; a securing member disposed on the base for securing the baseto a port on an endoscope; a locking member coupled to the outer shellfor securing the position of a medical device disposed in the opening; amulti-layer inner seal member disposed within the outer shell; whereinthe multi-layer inner seal includes a plurality of fingers disposedwithin the outer shell; and wherein at least some of the plurality offingers include a pad disposed on an end surface of the fingers.
 11. Anendoscope biopsy cap, comprising: an outer shell having an openingformed therein and a base; a securing member disposed on the base forsecuring the base to a port on an endoscope; a locking member coupled tothe outer shell for securing the position of a medical device disposedin the opening; a multi-layer inner seal member disposed within theouter shell; wherein the multi-layer inner seal includes a plurality offingers disposed within the outer shell; and wherein at least some ofthe plurality of fingers include a tether attached to an end surface ofthe fingers.
 12. The cap of claim 7, wherein a fluid is disposed withinthe outer shell.
 13. An endoscope biopsy cap, comprising: an outer shellhaving an opening formed therein and a base; a securing member disposedon the base for securing the base to a port on an endoscope; a lockingmember coupled to the outer shell for securing the position of a medicaldevice disposed in the opening; and a plurality of sealing membersdisposed within the outer shell, wherein the plurality of sealingmembers include a plurality of horizontally-oriented groups of flapsthat are stacked vertically.
 14. A method for using an endoscope, themethod comprising: providing an endoscope having a channel formedtherein and a port that provides access to the channel; disposing theendoscope within a body lumen of a patient; and disposing a cap on theport, the cap including: an outer shell having an opening formed thereinand a base, a securing member disposed on the base for securing the baseto the port, a locking member coupled to the outer shell for securingthe position of a medical device disposed in the opening, and an innerseal member disposed within the outer shell, wherein the inner sealmember includes a plurality of layers of flaps that are verticallyseparated from one another.